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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of February 9, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 868--ANESTHESIOLOGY DEVICES
Subpart A--GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B--DIAGNOSTIC DEVICES
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| Arterial blood sampling kit. |
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| Indwelling blood oxyhemoglobin concentration analyzer. |
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| Indwelling blood carbon dioxide partial pressure (P) analyzer. |
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| Indwelling blood hydrogen ion concentration (pH) analyzer. |
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| Indwelling blood oxygen partial pressure (P) analyzer. |
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| Carbon dioxide gas analyzer. |
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| Carbon monoxide gas analyzer. |
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| Nitrous oxide gas analyzer. |
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| Inspiratory airway pressure meter. |
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| Peak-flow meter for spirometry. |
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| Pulmonary-function data calculator. |
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| Predictive pulmonary-function value calculator. |
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| Diagnostic pulmonary-function interpretation calculator. |
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| Esophageal stethoscope with electrical conductors. |
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Subpart C--MONITORING DEVICES
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| Ultrasonic air embolism monitor. |
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| Uncompensated thorpe tube flowmeter. |
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| Compensated thorpe tube flowmeter. |
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| Gas calibration flowmeter. |
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| Breathing frequency monitor. |
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| Nitrogen dioxide analyzer. |
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| Cutaneous carbon dioxide (PcCO2) monitor. |
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| Cutaneous oxygen (PcO2) monitor. |
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| Electrical peripheral nerve stimulator. |
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| Differential pressure transducer. |
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Subparts D-E--[RESERVED]
Subpart F--THERAPEUTIC DEVICES
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| Device to relieve acute upper airway obstruction. |
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| Anesthesia conduction catheter. |
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| Anesthesia conduction filter. |
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| Anesthesia conduction kit. |
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| Anesthesia conduction needle. |
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| Gas machine for anesthesia or analgesia. |
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| Nitric oxide administration apparatus. |
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| Laryngotracheal topical anesthesia applicator. |
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| Anesthesia breathing circuit. |
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| Breathing circuit circulator. |
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| Breathing circuit bacterial filter. |
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| Carbon dioxide absorbent. |
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| Posture chair for cardiac or pulmonary treatment. |
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| Heat and moisture condenser (artificial nose). |
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| Electroanesthesia apparatus. |
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| Gas-scavenging apparatus. |
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| Portable oxygen generator. |
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| Respiratory gas humidifier. |
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| Therapeutic humidifier for home use. |
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| Membrane lung for long-term pulmonary support. |
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| Medicinal nonventilatory nebulizer (atomizer). |
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| Portable liquid oxygen unit. |
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| Electrically powered oxygen tent. |
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| Tracheal/bronchial differential ventilation tube. |
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| Inflatable tracheal tube cuff. |
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| Tracheal tube fixation device. |
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| Tube introduction forceps. |
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| Tracheal tube cleaning brush. |
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| Tracheostomy tube and tube cuff. |
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| Autotransfusion apparatus. |
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| Pressure tubing and accessories. |
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| Noncontinuous ventilator (IPPB). |
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| Manual emergency ventilator. |
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| Powered emergency ventilator. |
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| External negative pressure ventilator. |
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| Intermittent mandatory ventilation attachment. |
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| Positive end expiratory pressure breathing attachment. |
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Subpart G--MISCELLANEOUS
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| Anesthetic cabinet, table, or tray. |
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| Cardiopulmonary emergency cart. |
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| Tracheobronchial suction catheter. |
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| Patient position support. |
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| Medical gas yoke assembly. |
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